Close clinical surveillance of all women taking estrogens is important. Adequate
diagnostic measures, including endometrial sampling when indicated, should
be undertaken to rule out malignancy in all cases of undiagnosed persistent
or recurring abnormal vaginal bleeding. There is no evidence that the use
of “natural” estrogens results in a different endometrial risk profile than
synthetic estrogens at equivalent estrogen doses. (See WARNINGS,
Malignant neoplasms, Endometrial cancer.)

CARDIOVASCULAR AND OTHER RISKS

Estrogens with or without progestins should not be used for the prevention
of cardiovascular disease. (See WARNINGS, Cardiovascular
disorders.)

The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported
increased risk of developing probable dementia in postmenopausal women 65
years of age or older during 4 years of treatment with oral conjugated estrogens-plus-medroxyprogesterone
acetate relative to placebo. It is unknown whether this finding applies to
younger postmenopausal women or to women taking estrogen-alone therapy. (See
CLINICAL PHARMACOLOGY, Clinical Studies.)

Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

What are the precautions when taking estradiol vaginal cream (Estrace Vaginal Cream)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.